Advertisement

Topics

The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial

2014-08-27 03:17:43 | BioPortfolio

Summary

National recommendations state that patients with a history of transient ischemic attack (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm Hg systolic BP and <80 mm Hg diastolic BP. Statin treatment and lifestyle modification is also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of secondary stroke prevention, there is a gap between evidence and implementation in clinical practice. By a randomized controlled trial, the investigators will test whether a tailored, telephone-delivered transtheoretical model-based behavioral intervention will improve adherence to treatment in veterans with a history of TIA or stroke, thereby leading to better control of BP and cholesterol levels, as compared to an attention placebo.

The primary specific aims of this project are to:

- determine whether a behaviorally tailored intervention (TI) can effectively lower BP after 6 months of counseling as compared to an attention placebo (AP) in veterans with a history of stroke or TIA

- assess whether the TI is effective in improving adherence to diet after 6 months of counseling in veterans with a history of stroke or TIA.

Secondary aims are to

- assess whether the TI is effective in improving cholesterol levels in post-stroke veterans after 6 months

- evaluate whether the TI is effective in improving adherence to antihypertensive and lipid-lowering medications after 6 months of counseling in veterans with a history of stroke or TIA

- determine whether the TI is effective in improving adherence to exercise recommendations after 6 months.

To answer this, veterans (n=190) with a history of stroke or TIA will be randomized equally to the TI, which will use the transtheoretical framework to provide 6 monthly counseling phone sessions about adherence to diet, medication, and exercise recommendations, and the AP, in which 6 monthly counseling phone sessions about non-stroke-related health topics will be provided. Participants will make in-person visits at baseline and 6 months. BP (3 measures taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary outcomes will be total cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid-lowering drugs, and exercise adherence.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Conditions

Stroke

Intervention

tailored intervention, attention placebo

Location

VA New York Harbor Healthcare System, NY and Brooklyn Campuses
New York
New York
United States
10010

Status

Recruiting

Source

Narrows Institute for Biomedical Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:43-0400

Clinical Trials [2717 Associated Clinical Trials listed on BioPortfolio]

Development of a Tailored HIV Prevention Intervention for Young Men

This study uses an interactive design and development process to develop tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies. The study ...

Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke

There is an evidence gap on whether meditation may improve behaviorally measured attention after stroke, but preliminary research is promising. This study is the first-ever investigation o...

Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients

This proposed study will use previous study results to guide the development and evaluation of interventions to improve CRC screening acceptance. The proposed study will evaluate the impa...

Using SystemCHANGE™ to Enhance Medication Adherence in Older Adult Stroke Survivors

This study evaluated the feasibility and acceptability of using a SystemCHANGE intervention in older adult stroke survivors to improve medication adherence. Half the participants will rece...

Stroke COunseling for Risk REduction

The purpose of this study is to test the efficacy of the Stroke Counseling for Risk Reduction (SCORRE) intervention in increasing accuracy of perceived stroke risk and promoting lifestyle ...

PubMed Articles [9978 Associated PubMed Articles listed on BioPortfolio]

Sedentary behavior after stroke: A new target for therapeutic intervention.

Over the last 10 years, evidence has emerged that too much sedentary time (e.g. time spent sitting down) has adverse effects on health, including an increased risk of cardiovascular disease incidence ...

Walking Works Wonders: a tailored workplace intervention evaluated over 24 months.

This article presents longitudinal data from 1120 participants across 10 worksites enrolled in Walking Works Wonders, a tailored intervention designed to increase physical activity and reduce sedentar...

Individually-tailored multifactorial intervention to reduce falls in the Malaysian Falls Assessment and Intervention Trial (MyFAIT): A randomized controlled trial.

To determine the effectiveness of an individually-tailored multifactorial intervention in reducing falls among at risk older adult fallers in a multi-ethnic, middle-income nation in South-East Asia.

Development of a novel positive psychology-based intervention for couples post-stroke.

Stroke provides challenges for survivors and partner caregivers. Stroke survivors and caregivers are interconnected in their emotional health, including depression, a common stroke sequelae. The purpo...

The effectiveness of culturally tailored video narratives on medication understanding and use self-efficacy among stroke patients: A randomized controlled trial study protocol.

A substantial number of the world's population appears to end with moderate to severe long-term disability after stroke. Persistent uncontrolled stroke risk factor leads to unpredicted recurrent strok...

Medical and Biotech [MESH] Definitions

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

A study in which observations are made before and after an intervention, both in a group that receives the intervention and in a control group that does not.

Stroke caused by lacunar infarction or other small vessel diseases of the brain. It features hemiparesis (see PARESIS), hemisensory, or hemisensory motor loss.

A study that uses observations at multiple time points before and after an intervention (the "interruption"), in an attempt to detect whether the intervention has had an effect significantly greater than any underlying trend over time.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

More From BioPortfolio on "The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...

Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of affected individuals. Symptoms can range from mild breathles...


Searches Linking to this Trial